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RECRUITING
NCT07773129
PHASE1

A Study to Learn How ASP3082 is Processed in Healthy Men

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

Summary

Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers. To do this, \[14C\] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. \[14C\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \[14C\] will be picked up by a scanner and will be used to follow setidegrasib through the body. \[14C\]setidegrasib will be given as 1 single injection slowly through a vein (infusion). The men will stay overnight in the clinic for at least 2 weeks. They will give regular blood, urine and stool samples during their stay and will be closely monitored. The men will return to the clinic about 1 week later for a final safety check.

Official title: A Phase 1, Open-label Study to Evaluate the Metabolism and Excretion of [14C]ASP3082 in Healthy Adult Male Participants

Key Details

Gender

MALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-08-28

Completion Date

2026-10-31

Last Updated

2026-10-07

Healthy Volunteers

Yes

Interventions

DRUG

14C-labeled ASP3082

Intravenous infusion

Locations (1)

Fortrea Clinical Research Unit Inc.

Madison, Wisconsin, United States